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Legislation: A European regulation adopted on the packaging of medicinal products for human use will apply from 2019

Legislation: A European regulation adopted on the packaging of medicinal products for human use will apply from 2019

March 16th, 2016 - www.eur-lex.europa.eu

The regulation governing the identification of medicine packaging lays down the characteristics and technical specifications of the unique identifier to verify the authenticity of medicines and identify the individual packs. The unique identifier consists of a product code and a serial number. This unique identifier is part of a two-dimensional barcode (Data Matrix) also containing a batch number and expiry date of the medicine, and if necessary a national reimbursement number. The EU directive requires the integrity of the secondary packaging which must be fitted with an anti-tampering device.

The manufacturers will evaluate the Data Matrix quality of printing and print on the packaging (in a human-readable format) the product code, serial number, batch number, expiry date and national reimbursement number when necessary.

In case of suspected falsification, the pharmacist or persons authorized or entitled to supply medicinal products to the public will verify the safety features and will inform the relevant competent authorities.

The regulation will entry into force on February 9, 2019.

Read the Official Journal of the European Union L32 of Feb. 9, 2016: “Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.”